New rules for January 2021
The UK has left the EU, and the transition period after Brexit comes to an end this year.
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
- Getting your device certified
- Conformity marking your device
- Registering your device with the MHRA
This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules will apply to those in Great Britain after the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’
This guidance does not cover other ‘New Legislative Framework’ products, which are subject to separate guidance.
The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.
This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.
Summary of key requirements for placing a device on the Great Britain market
From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:
- CE marking will continue to be used and recognised until 30 June 2023
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
- 8 months for other Class IIb and all Class IIa devices
- 12 months for Class I devices
- The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
- If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person is set out below.